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Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study

Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study - Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051381
Enrollment
200
Registered
2023-06-20
Start date
2018-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric patients with chronic constipation

Interventions

None listed

Sponsors

Faculty of Medicine, Kyorin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Outpatients between 2 and 14 years of age at the time of initiation of treatment with MOVICOL. (2)Patients diagnosed with chronic constipation with a bowel movement frequency of once every 3 days or less during the week prior to administration of MOVICOL. (3) Patients newly prescribed and treated with MOVICOLfor at least 4 weeks between December 1, 2018 and December 31, 2022 (4)Patients with a record of defecation frequency prior to initiation of MOVICOL and for at least 4 weeks after MOVICOL administration.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of hypersensitivity to any ingredient of MOVICOL. (2)Patients with confirmed or suspected intestinal obstruction, intestinal perforation, or severe inflammatory bowel disease (ulcerative colitis, Crohn's disease, toxic megacolon disease, etc.) (3)Patients with suspected constipation due to organic disease (4)Patients who participated in clinical trials or interventional studies during the observation period (5)Patients who were outside the approved dosage and administration of MOVICOL.

Design outcomes

Primary

MeasureTime frame
Comparison of defecation frequency before and after 4 weeks of treatment.

Countries

Japan

Contacts

Public ContactYoshiko Watanabe

Faculty of Medicine, Kyorin University Department of Pediatric Surgery

nabey@ks.kyorin-u.ac.jp0422475511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026